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A Study of Amivantamab for Head and Neck Cancer

This study is investigating a new approach for recurrent or metastatic (cancer that has spread or returned) head and neck squamous cell carcinoma (HNSCC), a type of cancer that starts in the mouth or throat. It compares adding the drug amivantamab to standard treatments (pembrolizumab and carboplatin) against standard treatments alone (pembrolizumab, 5-fluorouracil, and carboplatin or cisplatin). The goal is to see if adding amivantamab improves how long people live (Overall Survival) and how much their tumors shrink (Objective Response Rate). You may be able to join if you are at least 18 years old and have HNSCC that has returned or spread and has not been treated before in this setting. The study aims to enroll about 500 participants, but its current status is unclear.

Study design
This is an interventional study comparing two treatment approaches for head and neck cancer. It plans to enroll about 500 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The study will measure outcomes like overall survival and tumor response for up to approximately 3 years and 7 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07276399

A Study of Amivantamab in Addition to Standard of Care Agents (SOC) Compared With SOC Alone in Participants With Recurrent/Metastatic Head and Neck Cancer

Recruiting
PHASE3Ages 18+InterventionalTreatment
Janssen Research & Development, LLC
~500 participants
Updated 2026-08-28 on ClinicalTrials.gov
What's tested:AmivantamabPembrolizumabCarboplatin5-FlurouracilCisplatin

At a glance

Recruiting sites
201 of 201 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Overall Survival (OS)
Measured over Up to approximately 3 years 7 months
+1 more outcome measured

Conditions

Squamous Cell Carcinoma of Head and Neck

Explore related trials

Head and Neck Squamous Cell Carcinoma

Where it's being run

201 sites across 43 states
China25
United Kingdom11
France9
Germany9
Spain9
Japan8
California7
Italy7

Study leadership

  • Janssen Research & Development, LLC Clinical Trial · STUDY_DIRECTOR · Janssen Research & Development, LLC

Who to contact

Study Contact
[email protected]
844-434-4210
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Eligibility criteria

Inclusion

Be more than or equal to (\>=) 18 years of age (or the legal age of majority in the jurisdiction in which the study is taking place, whichever is greater)
Have histologically or cytologically confirmed recurrent/metastatic (R/M) HNSCC that is considered incurable by local therapies: a. eligible primary tumor locations are the oral cavity, oropharynx, hypopharynx, or larynx; b. Must not have a primary tumor site of nasopharynx or primary tumor of unknown location; c. Must have documented local testing results per local regulations; d. Human papillomavirus (HPV) status must be known for participants with primary tumor location in oropharynx via p16 test, HPV DNA test, or high-risk HPV in situ hybridization (ISH). Any known p16, HPV DNA, or high-risk HPV ISH status of tumor must be negative
Be treatment-naive for systemic therapy in the R/M setting
Have an ECOG performance status of 0 or 1
Have measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) version (v).1.1

Exclusion

Have an uncontrolled illness
Have untreated brain metastases or history of known presence of leptomeningeal disease
Have a history of clinically significant cardiovascular disease
Inadequate organ or bone marrow function
Known allergies, hypersensitivity, contraindications, or intolerance to excipients of: Amivantamab, Pembrolizumab, Carboplatin, Cisplatin, 5-FU and Hyaluronidase

What this trial measures

  • Overall Survival (OS)Up to approximately 3 years 7 months

    OS is defined as time from the date of randomization to the date of death due to any cause.

  • Objective Response Rate (ORR) Using Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 as Assessed by Blinded Independent Central Review (BICR)Up to approximately 3 years 7 months

    ORR is defined as the percentage of randomized participants achieving a confirmed best overall response (BOR) of partial response (PR) or complete response (CR) by BICR using RECIST version 1.1 .